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Trial Title:
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
NCT ID:
NCT05844150
Condition:
SCLC
Conditions: Official terms:
Etoposide
Atezolizumab
Conditions: Keywords:
ES-SCLC
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
PM8002
Description:
IV infusion
Arm group label:
PM8002+Etoposide＋platinum
Intervention type:
Drug
Intervention name:
Platinum
Description:
IV infusion
Arm group label:
Atezolizumab+Etoposide＋platinum
Arm group label:
PM8002+Etoposide＋platinum
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
IV infusion
Arm group label:
Atezolizumab+Etoposide＋platinum
Intervention type:
Drug
Intervention name:
Etoposide
Description:
IV infusion
Arm group label:
Atezolizumab+Etoposide＋platinum
Arm group label:
PM8002+Etoposide＋platinum
Summary:
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the
efficacy and safety of PM8002 in combination with etoposide and platinum in first-line
treatment of extensive-stage small cell lung cancer
Detailed description:
The study is divided into two parts.
The first part is single-arm study, with a planned enrollment of at least 59 subjects.
The second part is randomized, double-blind study, this study plans to enroll 386
subjects, who will be randomized in a 1:1 ratio to an experimental group of PM8002 in
combination with chemotherapy (etoposide and platinum) and a control group of
Atezolizumab with chemotherapy (etoposide and platinum).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed informed consent form before any trial-related processes;
2. Age ≥18 years;
3. Histologically or cytologically confirmed ES-SCLC;
4. No prior systemic therapy for ES-SCLC;
5. Have adequate organ function;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of ≥12 weeks;
8. Had at least one measurable tumor lesion according to RECIST v1.1.
Exclusion Criteria:
1. Histologically or cytologically confirmed mixed SCLC;
2. History of severe allergic disease, severe drug allergy or have known allergy to any
component of the study drugs;
3. The toxicity of previous anti-tumor therapy has not been alleviated；
4. Have received anti-platelet therapy within 10 days prior to the first dose of the
study drugs;
5. Evidence and history of severe bleeding tendency;
6. History of severe cardiovascular diseases within 6 months;
7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
8. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ
transplantation;
9. History of alcohol abuse, psychotropic substance abuse or drug abuse;
10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
syndrome;
11. Pregnant or lactating women;
12. Other conditions considered unsuitable for this study by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Chen
Start date:
June 1, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Biotheus Inc.
Agency class:
Industry
Source:
Biotheus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05844150
